System and method for providing embolic protection

ABSTRACT

An apparatus for offering embolic protection is provided that includes a sponge operable to be positioned in an area of a patient who is to undergo a cardiovascular procedure. The sponge is operable to collect debris present in or proximate to the area and to allow a portion of blood flow or no blood flow associated with the area to continue while the debris is collected.

TECHNICAL FIELD OF THE INVENTION

This invention relates in general to cardiovascular diseases and, moreparticularly, to a process, a system, and a method for providing embolicprotection in a cardiovascular environment.

BACKGROUND OF THE INVENTION

The treatment of cardiovascular diseases has grown exponentially interms of sophistication and diversity. Procedures involving items suchas stents and balloons are virtually routine in most heart-carepractices. One problem associated with any cardiovascular procedure isdebris and/or clots, which can be detrimental to a patient's health.Debris is generally a byproduct of plaque, which is a friable material.Hence, during a routine stent, bypass, or balloon procedure, debris canbe present. During any such procedure, the debris may dislodge,fragment, or flake off and propagate to undesired areas of the patient.Such debris can manifest itself in the form of new blockages or bloodclots: both of which can easily lead to heart attacks, strokes, kidneyfailures, amputations, etc.

Thus, these issues can be problematic for the patient and for thetreating physician. Moreover, this harmful brittle material must beaccounted for because it is so delicate, friable, and easily disturbed.Therefore, the ability to properly account for debris during a givencardiovascular procedure presents a significant challenge for physiciansrelegated the difficult task of controlling this issue.

SUMMARY OF THE INVENTION

From the foregoing, it may be appreciated by those skilled in the artthat a need has arisen for an improved process for achieving superiorembolic protection during any number of cardiovascular procedures andprocesses. In accordance with an embodiment of the present invention, aprocess, a system, and a method for controlling debris and embolis areprovided that substantially eliminate or greatly reduce disadvantagesand problems associated with conventional cardiovascular diseaseapproaches, strategies, and instruments.

According to an embodiment of the present invention, an apparatus foroffering embolic protection is provided that includes a sponge operableto be positioned in an area of a patient who is to undergo acardiovascular procedure. The sponge is operable to collect debrispresent in or proximate to the area and to allow a portion of or noblood flow associated with the area to continue while the debris iscollected.

In more particular embodiments, the apparatus may include a guide wire(of any suitable length) coupled to the sponge. Additionally, theapparatus may include one or more additional sponges that are coupled tothe guide wire and that are operable to facilitate the portion of theblood flow while collecting the debris. In more specific embodiments,the sponge that is used during the cardiovascular procedure is operableto perform a sweeping function in the area when it is removed.

Alternatively, the sponge includes one or more edges that limit snaggingin the area when the sponge is moved. In still other alternativeembodiments, the sponge includes one or more grooves that are operableto collect the debris and to deposit at least a portion of the debris ina reservoir included in the sponge.

Certain embodiments of the present invention may provide a number oftechnical advantages. For example, according to one embodiment of thepresent invention, an architecture and a process are provided that offera flexible system, which can easily conform to the shape of the targetlocation. This would allow the present invention to have a broad rangeof applications, and be used in any number of (potentially awkward)environments. Moreover, the proffered sponge system of the presentinvention is atraumatic, as it offers only a minimal disruption to anassociated surgical (or intervened) region.

In addition, the configuration of the sponge system is “always on,”providing a solution that is continuously deployed and that consistentlyprotects any vulnerable region within a given patient. Thus, the spongesystem of the present invention is always actuated, which provides anumber of additional benefits. For example, because of the “always on”feature, a surgeon is no longer burdened with having to trigger any typeof filtering mechanism during a procedure. Also, the sponge iscompletely actuated once it emerges from a delivery catheter. Thisactuation exists during a procedure, during preparation for theprocedure, and during the post-procedure tasks (e.g. removinginstruments). The sponge system only stops being effective once it hasbeen removed from the patent site. Moreover, the sponge system allowsfor perfusion, as blood flow is not unnecessarily restricted. This wouldallocate more procedure time for a physician to complete his objectives.

The present invention also provides for enhanced versatility in itsapplications, as it can readily be applied to virtually any procedure.This could include operations and protocols that involve the carotidartery, as well as numerous other vascular procedures.

Certain embodiments of the present invention may enjoy some, all, ornone of these advantages. Other technical advantages may be readilyapparent to one skilled in the art from the following figures,description, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

To provide a more complete understanding of the present invention andfeatures and advantages thereof, reference is made to the followingdescription, taken in conjunction with the accompanying figures, whereinlike reference numerals represent like parts, in which:

FIG. 1 is a simplified schematic diagram illustrating a patient that maysubjected to an example cardiovascular procedure;

FIG. 2 is a simplified schematic of a heart within the patient of FIG.1;

FIG. 3 is a simplified schematic diagram of a sponge system that may beused in the heart of FIG. 2;

FIGS. 4A, 4B, and 4C are simplified schematic diagrams of the spongesystem: collectively demonstrating one potential deployment andextraction thereof;

FIGS. 5A-N are simplified schematic diagrams of various exampleconfigurations of the sponge system according to some of the teachingsof the present invention; and

FIG. 6 is a simplified flowchart illustrating a number of general stepsassociated with one implementation of the sponge system.

DETAILED DESCRIPTION OF THE INVENTION

For purposes of teaching and discussion, it is useful to provide someoverview as to the way in which the following invention operates. Thefollowing foundational information may be viewed as a basis from whichthe present invention may be properly explained. Such information isoffered earnestly for purposes of explanation only and, accordingly,should not be construed in any way to limit the broad scope of thepresent invention and its potential applications.

During cardiovascular procedures, there is a need to catch debris goingdownstream (i.e. any area in the downstream direction of blood flow).This need is particularly important in arteries, or in vein grafts. Notethat a number of procedures (e.g. stents, balloons, etc.) involvefriable materials that have a propensity to break apart and generateunwanted debris. The field is generally referred to as “embolicprotection.” The term “debris” as used herein in this document refers toany undesired or unwanted material at (or proximate to) the surgerysite/area. This debris could be present anywhere in the vasculatureand/or in any number of cardiovascular procedures (e.g. involving anaorta, graft, balloon angioplasty, carotid artery, renal artery, femoralartery, lower leg location, etc.).

The term “collect” as used herein in this document refers to anyactivity associated with capturing, confining, attracting, holding, orcatching debris in a given area. The term “sponge” as used herein inthis document refers to any compressible material, which may or may notbe sponge-like in its structure, for collecting debris. The sponge maybe designed based on any particular compression properties and,accordingly, be fitted or manufactured with particular cardiovascularenvironments in mind. Considerable flexibility is provided by the spongeof the present invention, as it can be modified, changed, or configuredin any suitable structure or arrangement.

Current devices to address embolic protection are diverse in theirprotocols, strategies, and technologies. For example, some tools employthe use of a balloon. During such a balloon endeavor, a given conduit orpassageway can be occluded, whereby subsequent work is performed, andprevalent debris is prohibited from moving downstream. Other devicesinclude the use of a wire-based mesh device, which reflects abasket-type apparatus. Whether it is a proximal occlusion or arudimentary filtering net, these devices and approaches suffer from anumber of shortcomings.

For example, many of these devices are cumbersome, which requires evengreater dexterity and precision for those individuals relegated thearduous task of performing associated cardiovascular operations. From aneconomic perspective, many of these devices are also problematic becausethey are expensive. Their excessive (and sometimes cost-prohibitive)price tags are generally due to their sophistication, complexity, anddelicacy. Note that such heightened complexity in some of these devicesdemands a certain level of expertise to successfully operate them.Moreover, such delicate instruments are difficult to deliver,challenging to extract, and, further, are often inefficient incollecting debris.

At a more fundamental level, these devices are flawed because theysimply fail to trap all of the debris at the target location. In somecases, this may be due to an imperfect occlusion. In other cases, thesedeficiencies in capturing material are present because the filteringsystem is faulty. From a flexibility standpoint, current systems arealso unsatisfactory. Many configurations are simply too rigid andinflexible for their intended applications. Consider the case where anoblong canal is implicated by a given procedure. It is exceptionallydifficult to protect such an awkward channel from potential debris thatis present at the surgery site or area. In worst-case scenarios, aphysician may opt to refrain from performing operations in such an areabecause the risk for debris may be too high. If the device is shaped ina crude manner such that friction is generated during contact withinterior walls, then the device may cause undesired trauma and rupturethe aforementioned plaque, as outlined supra. Note that many devices areconstructed of metal, which is conducive to the identified traumascenario.

Referring back to FIG. 1, FIG. 1 offers a sponge system 10 that isdesigned to overcome these shortcomings, and others, in offering anoptimal solution for embolic protection. FIG. 1 includes a patient 12,having a heart, which is generally indicated at 16, and an aorta 20 thatextends from heart 16, along the spinal cord, and to the legs of patient12. For purposes of performing a cardiovascular procedure, a surgeon maycreate an entry point 24, from which a catheter 26 may be inserted. Asimple gripping mechanism or an introductory element 28 (e.g. a plastictube) may be provided to adjust or to manipulate catheter 26 to anysuitable location. Introductory element 28 is generally just part of theintroductory sheath system, which can accommodate particular curvaturesand remain at entry point 24 of patient 12 throughout the procedure. Incertain embodiments, introductory element 28 can be used for flushingoperations and, further, be used to ensure that air or clots are notpresent during the procedure. The introductory sheath generally includesa lumen that is sufficient to accommodate all of the equipmentidentified herein (e.g. balloon, stent, sponge, etc.). In the coronarysystem (or in renals, in carotids, in vein grafts, etc.), the lumencould be in the range of 1.0-8.0 millimeters in diameter and/or bedesigned based on particular needs. (Note that most vein grafts maygenerally be in the range of 3.0-6.0 millimeters. In aorta systems, thisrange could be much higher (e.g. 30-60 millimeters in diameter)).

Catheter 26 may be fed through entry point 24 and propagate along aorta20 until it reaches its intended destination. A series of arrows 34 areprovided in order to illustrate one example pathway associated withsponge system 10, whereby the attending surgeon may guide catheter 26 inany suitable fashion. In operation of an example embodiment, a sheathmay be placed in the right or left groin, whereby entry point 24 isincised at the femoral artery. The sheath would be positioned at entrypoint 24. The sheath is simply a tube of some type (e.g. plastic, glass,etc.) that can be used as a conduit and from which other instruments maybe delivered.

Catheter 26 could then be placed in entry point 24 and propagate alongaorta 20. Sponge system 10 could be inserted at entry point 24, as thesheath can easily constrain any sponge arrangement. Sponge system 10would then offer embolic protection at the target site, which may bedetermined by the treating physician. Sponge system 10 can filterparticles, while allowing blood to pass through a given region.Additional details relating to this process and the capabilities ofsponge system 10 are provided below with reference to FIGS. 2-6.

Referring now to FIG. 2, FIG. 2 illustrates additional detailsassociated with the procedure described above. FIG. 2 is a simplifiedschematic diagram of heart 16 of FIG. 1. For purposes of example andteaching, heart 16 is described as experiencing a number of blockagessuch that a balloon procedure is recommended for patient 12. Inparticular, patient 12 had a previous blockage (some ten years ago) thatnecessitated a bypass operation of a coronary artery. Now, patient 12 isexperiencing chest pain, dizziness, etc. because of a narrowing in agiven vein (presumably from his leg) associated with this bypass. Theballoon procedure that was elected could readily employ sponge system 10to prevent debris from traveling to undesired locations. Note that suchdebris is detrimental and lethal to patient 12, as it can easily causeheart attacks, strokes, and/or form future blockages for patient 12. Inother scenarios, such debris could lead to kidney failures, amputations,etc.

In a normal balloon procedure, which could ostensibly include a stent orany other appropriate device, while patient 12 is awake, catheter 26 isinserted into an artery at the top of the leg (i.e. the femoral artery)at entry point 24. The procedure generally begins with the doctorinjecting some local anesthesia into the groin area and putting a needleinto the femoral artery (the blood vessel that runs from the heart downthe leg). Once the needle is inserted, a guide wire is placed throughthe needle and into the blood vessel. Following this step, the guidewire is left in the blood vessel and the needle is removed.

A flexible system, often called an “introducer,” is placed over theguide wire and the guide wire is removed. Next, a diagnostic catheter,which is a long narrow tube, is advanced through the introducer over aguide wire and into the blood vessel. The catheter is then guided to theaorta and the guide wire is removed. Once the catheter is placed in theopening of one of the coronary arteries, the doctor may inject dyeand/or take a series of images.

FIG. 3 illustrates additional details related to the balloon procedure.FIG. 3 is a simplified schematic diagram of heart 16, which includes abypass 44 (i.e. a leg vein) that is experiencing a current blockage.Bypass 44 includes various formations of plaque 46, which may flake offand produce debris 48. FIG. 3 also illustrates a guide 40, which isaccompanied by a guide wire 42 and a sheath 54. Note that a portion ofsheath 54 and guide 40 is behind heart 16, which is why they areillustrated by dashed lines at certain locations. Through guide 40,sheath 54 and all other requisite materials are passed (e.g.introductory catheter, delivery catheter, removal catheter, spongeconfiguration, etc.). A sponge 50 is also provided that is suitablyfixed to guide wire 42. Note that guide wire 42 may be of any suitablelength: such length being determined based on particular needs orspecific environments. For example, shorter guide wires 42 may be usedin carotid procedures.

Continuing with the balloon procedure, the first catheter isexchanged-out over guide wire 42 for a guiding catheter. Potentially, asmaller guide wire is also advanced across the blocked section of thevein and a balloon-tipped tube is generally positioned so the balloonpart of the tube is beside the blockage. The balloon is then inflatedfor a few seconds to compress the blockage against the wall of the vein.Then the balloon is deflated.

The doctor may repeat this inflation technique a few times, each timepumping up the balloon a little more to widen the passage for the bloodto flow through the conduit. This treatment is routinely repeated ateach blocked site in the coronary arteries. A stent (not shown) may thenbe placed at the now-unblocked passageway. A stent is a latticed, metalscaffold that is placed within the coronary artery (or vein in thisexample) to keep the vessel open.

During all of these procedures, debris 48 is likely to be present. Thedebris is detrimental to patient 12 and, thus, needs to be accountedfor. In the example of FIG. 3, a triangular, cone-shaped sponge 50 issuitably positioned to capture any debris 48 that is prevalent duringthe procedure.

Debris 48 from plaque (or any other source) can generally flake off andpropagate downstream. Debris is generally friable and normally involvesmultiple layers. For example, a hard layer of plaque may be present in agiven vessel, whereby softer material is present at a surface level.Surface material is particularly detrimental, as it is easilydistributed by instruments (which are often metal) used in mostcardiovascular procedures. Free moving (uncaptured) debris 48 cannaturally cluster and subsequently clog or block a vessel, which couldproduce a heart attack. The same scenario can involve a carotid artery.For example, during a routine stent or balloon procedure, debris 48 canbe present and, thereby, cause any of the aforementioned problems:particularly stroke. Hence, in other applications, sponge 50 couldaddress this vulnerability and, thus, be rather large (e.g. 30-60millimeters). This sponge arrangement could cover an entire aorta. Thiscould involve protection in neck arteries. However, larger sponges wouldrequire greater expertise and dexterity on the part of the operatingsurgeon, as larger sponges are more difficult to remove/withdraw.

Sponge 50 may be suitably coupled to guide wire 42 in any appropriatemanner. This may include a piercing of sponge 50, whereby some type ofstop mechanism is provided at the end of sponge 50. Alternatively,sponge 50 may be glued to guide wire 42 or slide freely along guide wire42, where appropriate. In other scenarios, sponge 50 may be moldedaround guide wire 42. The present invention contemplates considerableflexibility in the manner in which sponge 50 is fixed: either to guidewire 42 or to any other suitable element in order to facilitate itsoperations.

While the surgeon or the technician is performing any number of tasksassociated with patient end user 12, debris 48 is effectively capturedby sponge 50. Concurrently, blood flow continues, as sponge 50 does notunnecessarily restrict the downstream propagation of blood. Hence,sponge 50 is continuously providing protection for patient 12, whileoptimizing blood flow during the operation. No longer would a devicenecessarily occlude an entire portion of the heart (although in certainapplications, sponge 50 can completely restrict blood flow). Nor wouldsuch a device traumatize a given area, which may be subjected tojostling and shifting caused by the procedure.

Hence, sponge system 10 is adequately configured such that itfacilitates blood flow as it protects against harmful debris 48. Hence,a perfusion-type mechanism is achieved concurrently with capturingdestructive debris that have a propensity to flow downstream of thesurgical (or intervened) area. In certain instances (e.g. in certainprocedures involving the aorta), no blood flow is desired to propagatedownstream. Sponge 50 could readily accommodate these scenarios andcompletely restrict blood flow in these instances.

Note also that the intrinsic nature of sponges allows them to beretracted quite easily. Because of their compression properties, as wellas their malleability, sponges are ideal in such cardiovascularprocedures. Each sponge 50 may be designed with any appropriate porosityproperties such that only the proscribed amount of perfusion isachieved. Similarly, sponge 50 may be designed only to swell to acertain degree or to hold only a specific amount of debris or fluid atany one time. Note that sponge 50 may be designed such that optimalcontrol of blood flow is achieved. For example, in a sponge system thatincludes a circular design (having a number of spherical shapes forexample), a number of holes could be provided in the elements so thatthe blood flow could go through a single unit and then flow to the nextunit. In this fashion, a number of holes could accommodate perfusion,but also be able to redirect blood flow from one unit to the next.Hence, holes could readily be provided in any given sponge 50: some ofthe holes being offset from each other in certain instances. Any suchconfigurations or any permutations of these concepts are clearly withinthe scope of the present invention.

In other instances, sponge 50 may be designed to completely occlude agiven area. In addition, each sponge 50 may be constructed with aspecific rigidness or flexibility (e.g. on a scale from ‘soft’ to‘hard’). Thus, sponge 50 may include properties that may be based onparticular needs and configurations. Note that blood is about 8 microns.The material to be caught by sponge 50 can be in the range of 15-200microns. In alternative embodiments, sponge 50 may be designed with anyrequisite properties where appropriate and be specific to individualapplications.

Thus, sponge 50 offers an architecture that can easily conform to theshape of the target location. This would allow the present invention tohave a broad range of applications. Moreover, sponge 50 is atraumatic,as it offers only a minimal disruption to an associated region.Therefore, during a normal stent or balloon procedure, debris 48 wouldremain relatively undisturbed during the operation. In the unlikelychance that debris 48 would materialize or surface, then sponge 50 wouldbe prepared to capture it.

Hence, the sponge configuration is “always on,” providing a solutionthat is continuously deployed and that consistently protects anyvulnerable area within a given patient. Sponge 50 is always actuated,which provides a number of additional ancillary benefits. For example,because of the “always on” characteristic, a physician is no longerburdened with having to trigger any type of filtering mechanism while heis performing a procedure. Also, sponge 50 is completely actuated onceit emerges from a delivery catheter or guide 40. This actuation existsduring a procedure, during preparation for the procedure, and during thepost-procedure tasks (e.g. extracting instruments). Sponge 50 onlyceases being effective once it has been removed from the patient site.As identified above, sponge 50 also provides for enhanced versatility inits applications, as it can readily be applied to virtually anyprocedure.

FIGS. 4A, 4B, and 4C are simplified schematic diagrams of sponge 50 andone potential deployment/extraction thereof. In operation, the sponge(or sponges) can be loaded into sheath 54 and/or guide 40 in order toinitiate the embolic protection mechanism of the present invention.Sponge 50 may be suitably compressed within sheath 54 before beinginserted into patient 12. Once the associated cardiovascular procedurehas been completed, sponge 50 may then be properly withdrawn withminimal effort and little trauma to patient 12. Sponge 50 could readilybe collapsed into (constraining) sheath 54 such that is can extendbeyond the target area. Once constraining sheath 54 has released sponge50, sponge 50 is ready to begin capturing the debris.

In retrieving sponge 50, an extraction sheath 60 may be utilized. Thisis illustrated in FIG. 4C. In one embodiment, extraction sheath 60 maybe slightly larger than sheath 54. Additionally, extraction sheath 60may be used for aspiration (e.g. removing fluids or gases with a suctiondevice). Extraction sheath 60 would also allow some of the debriscollected by sponge 50 to be removed before the surgical cite is exited.

Sponge 50 may be designed to have enough filtering capability toadequately collect materials at a surgical area. Unlike other filtrationsystems, sponge 50 may be designed in a particular embodiment to includeporosity characteristics that allow for blood flow for areas downstreamof the target area. The human body can generally tolerate approximately2-3 minutes of a lack of blood flow in most cardiovascular procedures.However, balloon and stent procedures can easily take 5-6 minutes, andeven extend further in some instances. Moreover, such proceduresgenerally implicate a number of individuals, who have to participate inthe procedure. The architecture of sponge 50 does not starve thedownstream area of blood flow needlessly (unless such a deprivation ispreferred, in which case sponge 50 can accommodate this). This, in turn,effectively removes the limited timing constraints, which are present inother systems. In addition, such a system can be operated by a singlephysician, which avoids complexity and unnecessary coordination amongstan entire team of cardiologists (or physicians). Also, this eliminationof participants and complexity is amendable to condensed surgicalprocedures. A significant number of precautions and steps areeffectively avoided as a result of the configuration of sponge system10.

FIGS. 5A-N are simplified schematic diagrams of various exampleconfigurations of sponge system 10 according to some of the teachings ofthe present invention. FIG. 5A is a circular-shaped sponge 50; FIG. 5Bis a square-shaped sponge 50; FIG. 5C is a trapezoid-shaped sponge 50;FIG. 5D is a rectangular-shaped sponge 50; FIG. 5E is atriangular-shaped configuration sponge 50 arrangement, which includes analternating pattern; FIG. 5F is a triangular-shaped series configurationsponge 50 arrangement; FIG. 5G is a triangular-shaped configurationsponge 50, which uses opposing elements; FIG. 5H is a circular-shapedsponge 50 arrangement that includes progressively larger elements; FIG.5I is a circular-shaped sponge 50 configuration that includes a seriesof elements; and FIG. 5J is an hourglass-shaped sponge 50. Note that theexamples of FIG. 5 offer just some of the possible arrangements of agiven sponge in accordance with the teachings of the present invention.These designs may be changed, modified, combined, or added to whereappropriate and based on particular needs. Using analogous reasoning, itshould be noted that these arrangements are not exhaustive, as otheralternatives and permutations of sponge 50 are clearly within the broadscope of the present invention.

Note that the series configurations (i.e. multiple sponge elements beingprovided along a given wire or guide) illustrated in FIG. 5 areconducive to utilization in smaller catheters, as well as reductions inother ancillary equipment. Thus, a series of sponges 50 can effectivelybe used to gather and collect all debris 48 in confined target areas.

Note that a series of edges 58 (e.g. on every edge or at any selectedand appropriate location of sponge 50) could also be provided on any ofsponges 50. Edges 58, which are illustrated in FIG. 5C, could be used toavoid snagging (and/or trauma), as sponge 50 is removed. Edges 58, whichmay be plastic or constructed of any other suitable snag-resistantmaterial, may be provided in any of the other embodiments as describedherein. In addition, a somewhat elastic coating (e.g. plastic) could beplaced on the entire surface of sponge 50 such that the aforementionedsnagging issue is effectively avoided. The coating could provide anoverall resiliency to sponge 50.

In still other embodiments, drug delivery could be facilitated by thepresent invention, whereby sponge 50 is coated with some agent (e.g. forstimulating growth or rapid healing, for alleviating pain or discomfort,for thinning blood, etc.). Once suitably positioned, the drug couldrelease at the surgical site or via the blood stream of patient 12.

FIG. 5K illustrates a series of grooves 70, which can be used to collector to direct blood flow to a reservoir 74. Note that as used herein inthis document, “grooves” refers to any slat, hole, pore, crease, oropening that affects or influences the direction of blood flow orplaque. Note also that grooves 70 have been exaggerated in theillustration to emphasize their ability to direct blood flow or plaque.In other embodiments (e.g. those that involve simple holes and/orpores), grooves 70 could be relatively small and formed into anyparticular shape (e.g. circle, square, slat, triangle, etc.). Unlikeconventional sponges that universally collect matter on their surfaces,sponge 50 may be designed in order to have the collected contentsdeposited internally (i.e. in reservoir 74). Hence, sponge 50 allowspreferential areas within its internal structure to receive thecollected debris. Thus, the collected material (debris 48) isinternalized: as opposed to externalized, which can be problematic whenremoving sponge 50. Loose debris 48 could be an issue during removal ofany of the equipment identified herein. Hence, any sponge 50 could usethe groove-reservoir arrangement. Corkscrew and whirlwind configurationscould also be used to capture debris 48 in accordance with the presentinvention. These are illustrated in FIGS. 5L-M. Lastly, FIG. 5Nillustrates a series of connected circular sponges 50, which have nospace between them. This offers yet another example configuration ofsponge 50.

Note that, as identified above, sponge 50 may be designed in a way suchthat optimal perfusion occurs. For example, in the context of FIG. 5N, aseries of pores or holes could be provided in each lobe. One lobe couldhave more pores than another lobe. Using these pores or holes (which areincluded within the broad rubric of grooves), perfusion can becontrolled. The placement and/or size of the holes could similarly bemanipulated to achieve the effect that is desired.

FIG. 6 is a simplified flowchart illustrating a series of example stepsassociated with sponge system 10. The method may begin at step 100 wheresponge 50 is collapsed and inserted into a given retraction element(e.g. a guide, a catheter, a sheath, etc.). At step 102, the retractionelement is suitably positioned at the surgical area. Work is thenperformed at the surgical area (e.g. an angioplasty, a stent procedure,a bypass, a balloon procedure, etc.). At step 106, sponge 50 effectivelycaptures any debris (or other materials) that are present and which areunwanted. The capturing capability is activated the moment that sponge50 emerges from the retraction element.

Equipment and tools are then removed from the patient site at step 108.While being removed, sponge 50 potentially performs a sweeping and/or acleaning function. Sponge 50 may then be discarded, evaluated (e.g. forbiopsy studies), or cleaned for future use where appropriate. In thecase of a biopsy, all of the material collected by sponge 50 (not justdebris) may be evaluated.

It is important to note that the stages and steps in FIG. 6 illustrateonly some of the possible scenarios that may be executed by, or within,the present system. Some of these stages and/or steps may be deleted orremoved where appropriate, or these stages and/or steps may be modifiedor changed considerably without departing from the scope of the presentinvention. In addition, a number of these operations have been describedas being executed concurrently with, or in parallel to, one or moreadditional operations. However, the timing of these operations may bealtered considerably. The preceding example flows have been offered forpurposes of teaching and discussion. Substantial flexibility is providedby the tendered architecture in that any suitable arrangements,chronologies, configurations, and timing mechanisms may be providedwithout departing from the broad scope of the present invention.

Note also that the example embodiments described above can be replacedwith a number of potential alternatives where appropriate. The processesand configurations discussed herein only offer some of the numerouspotential applications of sponge system 10. The elements and operationslisted in FIGS. 1-6 may be achieved with use of sponge system 10 in anynumber of contexts and applications. Accordingly, suitableinfrastructure may be included within sponge system 10 to effectuate thetasks and operations of the elements and activities associated withmanaging embolic protection.

Although the present invention has been described in detail withreference to particular embodiments in FIGS. 1-6, it should beunderstood that various other changes, substitutions, and alterationsmay be made hereto without departing from the sphere and scope of thepresent invention. For example, although the preceding FIGURES havereferenced a number of components as participating in the numerousoutlined procedures, any suitable equipment or relevant tools may bereadily substituted for such elements and, similarly, benefit from theteachings of the present invention. These may be identified on acase-by-case basis, whereby a certain patient may present a health riskfactor while another (with the same condition) may not. Hence, sponge 50may be designed based on particular needs with particular scenariosenvisioned. This could include modifying (cutting, trimming,compressing, combining with any other element, etc.) sponge 50 by thesurgeon ‘in situ’ or prior to the surgery.

In other alternatives, a retraction (or export or extraction) cathetermay not even be necessary. In such a scenario, sponge 50 could perform afinal sweeping or cleaning function for the target area, as highlightedsupra. Because of the inherent properties of sponge 50, it is generallyresistant to snagging and, thus, could easily perform such an operationwith little trouble.

Numerous other changes, substitutions, variations, alterations, andmodifications may be ascertained to one skilled in the art and it isintended that the present invention encompass all such changes,substitutions, variations, alterations, and modifications as fallingwithin the spirit and scope of the appended claims. In order to assistthe United States Patent and Trademark Office (USPTO) and additionallyany readers of any patent issued on this application in interpreting theclaims appended hereto, Applicant wishes to note that the Applicant: (a)does not intend any of the appended claims to invoke paragraph six (6)of 35 U.S.C. section 112 as it exists on the date of filing hereofunless the words “means for” are specifically used in the particularclaims; and (b) does not intend by any statement in the specification tolimit his invention in any way that is not otherwise reflected in theappended claims.

1. An apparatus, comprising: a single sponge operable to be positioned in an area of a patient who is to undergo a cardiovascular procedure, wherein the sponge is operable to collect debris present in or proximate to the area and to allow a portion of blood flow or no blood flow associated with the area to continue while the debris is collected, whereby the sponge is capable of achieving a complete lack of blood flow to the area such that a full occlusion can occur at the area, wherein the sponge is operable to deliver a drug to the area, and wherein the drug is provided in or on the sponge, wherein a coating is disposed on a portion of the sponge, the coating operable to limit friction or snagging in the area.
 2. The apparatus of claim 1, further comprising: a guide wire coupled to the sponge, wherein the guide wire is a selected one of a group of guide wires having various lengths.
 3. The apparatus of claim 2, further comprising: one or more additional sponges that are coupled to the guide wire and that are operable to prohibit the blood flow in the area while collecting the debris.
 4. The apparatus of claim 1, wherein the sponge includes one or more grooves that are operable to affect the blood flow, and wherein one or more of the grooves may be positioned or sized in order to achieve a certain level of perfusion.
 5. The apparatus of claim 1, wherein the sponge includes one or more edges that limit snagging in the area when the sponge is moved.
 6. The apparatus of claim 1, wherein the sponge includes one or more grooves that are operable to collect the debris and to deposit at least a portion of the debris in a reservoir included in the sponge.
 7. The apparatus of claim 1, wherein the sponge is shaped in a specific form, the form being selected from a group of forms that consists of: a) a rectangular form; b) a square form; c) a sphere form; d) a triangular form; e) a trapezoid form; f) a whirlwind form; g) a corkscrew form; h) an hourglass form; and i) a cone form.
 8. The apparatus of claim 1, further comprising: a catheter that receives the single sponge in a compressed state such that the single sponge can be delivered to the area and subsequently deployed as it exits the catheter. 